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Leaseir MHR Xcell (console MHR-100b); Handpiece Dual (810-b and Blend-b); Handpiece Quad (810-b and Blend-b)

by Leaseir Technologies, Slu

510(k) K253251

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253251↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK253251 Date4 May 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GEX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Leaseir MHR Xcell is a powered laser system designed for soft tissue ablation and coagulation in surgical procedures. It operates using dual and quad handpieces with 810-nanometer and blend-mode wavelengths, enabling precise control for procedures in general and plastic surgery.

This device is supplied as a console (MHR-100b) paired with interchangeable handpieces, intended for reusable use in controlled clinical settings. It complies with FDA 510(k) clearance (K253251) under 21 CFR 878.4810 and EU MDR regulations, with no third-party involvement. Sterility and MRI safety are not specified in the data.

Other devices from Leaseir Technologies, S.L.U.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Leaseir MHR Xcell system primarily intended for?

    The Leaseir MHR Xcell system is designed for soft tissue ablation and coagulation during surgical procedures, particularly in general and plastic surgery. Its dual and quad handpieces, operating at 810-nanometer and blend-mode wavelengths, allow for precise control in these specialties.

  • How is the Leaseir MHR Xcell system supplied, and is it intended for single-use or reusable applications?

    The system is supplied as a console (MHR-100b) paired with interchangeable handpieces (Dual and Quad models). It is explicitly intended for reusable use in controlled clinical settings, meaning it is not a single-use device.

  • What regulatory pathways has the Leaseir MHR Xcell system followed, and where is it authorized for use?

    The device has received FDA 510(k) clearance (K253251) under 21 CFR 878.4810 and EU MDR compliance, with no third-party involvement. This means it is authorized for use in the U.S. and the European Economic Area under these respective regulatory frameworks.

  • Does the Leaseir MHR Xcell system include multiple handpiece options, and what wavelengths do they use?

    Yes, the system includes two types of handpieces: a Dual handpiece (810-b and Blend-b) and a Quad handpiece (810-b and Blend-b). Both operate at 810-nanometer and blend-mode wavelengths, enabling flexibility in surgical precision.

  • Is the Leaseir MHR Xcell system compatible with MRI environments, and what is its sterility status?

    The provided data does not specify MRI safety or sterility for the Leaseir MHR Xcell system. Clinicians should verify compatibility with their facility’s MRI protocols and follow manufacturer guidelines for sterilization if reuse is required.